Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients

Abstract

Objective: To determine whether a brief self-administered cognitive coping and relaxation intervention (CCRI) would lead to decreased treatment termination in in vitro fertilization (IVF) patients compared with routine care (RC).

Design: Randomized, controlled, prospective study.

Setting: Private academically affiliated infertility center.

Patient(s): One hundred sixty-six women about to begin their first IVF cycle.

Intervention(s): Randomization to the self-administered CCRI or RC control group and then observation for 12 months.

Main outcome measure(s): Treatment discontinuation within 12 months (primary outcome), clinical pregnancy rate and psychological well-being (secondary outcomes).

Result(s): The 12-month pregnancy rate was similar for the RC and CCRI groups (odds ratio [OR] 1.02; 95% CI, 0.53-1.98). Of the patients who were not pregnant on the first cycle, 15 of 46 (15.2%) patients assigned to RC discontinued compared with 5 of 55 (5.5%) patients assigned to the CCRI (OR 3.11; 95% CI, 0.756-12.80). The CCRI group engaged in statistically significantly more positive reappraisal coping (OR 0.275; 95% CI, 0.16, 0.39) than the RC control group (OR 0.097; 95% CI, -0.03, .23). The CCRI group had an improved Fertility Quality of Life (FertiQoL CORE: OR 4.07; 95% CI, 2.07, 6.06; FertiQoL Emotional: OR 5.95; 95% CI, 2.89, 9.00) compared with the control group (Core OR: 0.67; 95% CI, -1.55, 2.89; Emotional: OR -0.02, 95% CI, -3.36, 3.32). The CCRI group reported less global anxiety (OR 0.275; 95% CI, 0.16, 0.39) than the control group (OR 0.471; 95% CI, -2.40, 3.34). The CCRI reported positive evaluations for the intervention (e.g., ease of use, helpfulness, perceived stress reduction).

Conclusion(s): Use of the CCRI tool led to improved psychological status but not statistically significantly more treatment cycles or a higher pregnancy rate.

Clinical trial registration number: NCT01318291.

Keywords: Cognitive coping and relaxation intervention; IVF; Positive Reappraisal Coping Intervention; compliance; depression; discontinuation; dropout; stress management.